Laura Hatcher serves as the Associate Director of TMF Operations at Spark Therapeutics, Inc., where she plays a pivotal role in ensuring the integrity and compliance of the Trial Master File (TMF) throughout the clinical trial lifecycle. With her advanced knowledge of Veeva Vault eTMF...
Laura Hatcher serves as the Associate Director of TMF Operations at Spark Therapeutics, Inc., where she plays a pivotal role in ensuring the integrity and compliance of the Trial Master File (TMF) throughout the clinical trial lifecycle. With her advanced knowledge of Veeva Vault eTMF and CDISC Reference Model 3.2.0, Laura is instrumental in overseeing the implementation and maintenance of electronic TMF systems, ensuring that all documentation adheres to regulatory standards and best practices. Her expertise in IRB submission and regulatory document preparation further enhances her capability to navigate the complexities of clinical trials, making her a valuable asset to the organization.
In her current role, Laura is accountable for the overall management of the TMF function, focusing on content quality and proactive risk management. She leads the charge in the implementation of the Clinical Trial Management System (CTMS) at both organizational and project levels, ensuring seamless integration and functionality. Her well-developed leadership and organizational skills enable her to coordinate and oversee document management processes effectively, fostering a culture of compliance and excellence within her team.
Laura's proficiency in Microsoft Office Suite and advanced SharePoint knowledge allows her to leverage technology to streamline operations and enhance collaboration across departments. She embraces change and is always on the lookout for innovative solutions that can improve efficiency and data integrity. With a strong commitment to people development and project management, Laura not only drives the success of key projects but also mentors her team, ensuring that they are equipped with the skills and knowledge necessary to excel in the fast-paced world of clinical research. Her dedication to advancing TMF operations at Spark Therapeutics underscores her passion for improving patient outcomes through innovative therapies.
